Director of Quality

Company Description

Kesin Pharma collaborates with healthcare providers to offer high-quality prescription and over-the-counter medications tailored for efficiency and reliability. Kesin Pharma is a fast-growing generics and repackaging company helping hospitals and health systems operate more efficiently. Our portfolio of unit-dose and bulk medications is built to meet the daily needs of hospital pharmacy operations while ensuring quality and reliability. Kesin Pharma ensures consistent quality and reliable supply. We are committed to supporting the demands of modern pharmacy operations with a focus on operational excellence.

Role Description

Ensure departmental compliance with FDA regulations, cGMPs, and all other applicable requirements, applicable department programs to include training, documentation, standard operating procedures, and Kesin Pharma Corporation policies.

Key Responsibilities

• Ensure compliance with all current Good Manufacturing Practices (cGMPs), SOPs, and facility safety standards as related to the equipment, work area, and personnel.
• Coordinate quality assurance efforts and audits to improve GMP processes and documentation.
• Responsible for client/supplier/vendor requests for documentation, protocols, and agreements.
• Collaborate with third-party laboratories on chemistry and microbiological testing requirements and approves Quality Control Testing Specifications.
• Verifies and approves laboratory test results and/or QA documentation.
• Institute stability requirements, and coordinate efforts of third-party laboratories and the company to establish stability trends and Best Used by Dates.
• Responsible for oversight of disposition of product at various stages and final disposition of finished goods.
• Collaborate in the training curriculum, supervising, developing, and supporting staff that are responsible for reviews of quality system records.
• Responsible for reporting quality issues to Operations or Facilities Management and overseeing the resolution of the issue, ensuring GMP standards.
• Leads investigation activities for Complaints and Deviations, performs root cause analysis, and develops CAPA plans as appropriate.
• Leads Change Control activities, assisting other departments as needed.
• Review of site Quality Documentation, including SOPs, Policies, Analytical Worksheets, and Material Specifications, to ensure compliance with site procedures and regulatory requirements.
• Prepare Master Batch Records, Master Packaging Records (where applicable),.
• Prepare and lead Change Control activities and execution of Validation activities.
• Master Labeling review, approval, and distribution.
• Ensures that cleaning validations and production equipment validations or re-assessments are performed and documented.
• Oversee retain/reserve sample management.
• Provide Quality oversight and support for warehouse operations.
• Provides periodic key performance reports to Executive Management as requested.
• Coordinate calibration efforts with Manufacturing and/or Engineering.

Qualifications

• Previous experience in pharmaceutical GMP environment.
• Knowledge of FDA regulations related to GMP.
• Thorough knowledge of quality control/assurance and/or operations.
• Must have experience of pharmaceutical in-process stages.
• Must have a good interpersonal and communication skill in English, understand both oral and written instructions, and be detail oriented.
• Must possess the ability to manage multiple projects with competing deadlines.
• General computer knowledge of basic software, i.e., Microsoft Word, Excel, email communication.
• BS/BA degree in science or other related discipline is preferred, or an equivalent combination of education, training, and experience.
• Able to stand, bend, and stoop for extended periods of time and ability to lift 45 lbs. unassisted.

What We Offer

• Competitive compensation.
• Opportunity to work with a collaborative and mission-driven team.
• Flexible work arrangements (where applicable).
• Professional growth in a dynamic pharmaceutical organization.
• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

The facility is in two neighboring buildings, and routine movement between buildings is required.